Lung Function After Abdominal Surgery

Completed

• Conditions: Lung Function; Postoperative Complications; Abdominal Surgery
• Interventions: Diagnostic Test: Lung function before and after surgery

• Registration Number: NCT04502420
• Lead Sponsor: Umeå University

Brief Summary

The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.

Inclusion: Patients undergoing surgery for abdominal surgery

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Investigation: The day before surgery and the day after surgery

Primary outcome measures:

* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.

* PaO2, PaCO2 and oxygen saturation (blood gas)

Detailed Description

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.

The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.

Design: Prospective cohort study

Inclusion: Patients undergoing surgery for abdominal surgery

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Method: The day before surgery and the day after surgery: Lung function (Vital capacity and FEV1) using box and diffusion capacity measurements and blood gas measurement

Primary outcome measures:

* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.

* PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery, previously known lung disease.

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Study Start: 2020-08-17
• Primary Completion: 2021-10-17
• Study Completion: 2021-10-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Adult patients (18 years old and older) scheduled for surgery in the abdomen at department of Surgery, Urology and Gynecologi, Umeå University hospital.
• Must be able to perform a lung function test

Exclusion Criteria

• Dementia or severe cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal surgery	Lung function before and after surgery	People who to be operated in the abdomen are investigated before and after surgery.

Primary Outcome Measures

Name	Time	Method
Diffusion capacity for carbon monoxide (DLCO)	Change from baseline (the day before surgery) to postoperative day 1 or 2	Change in DLCO

Secondary Outcome Measures

Name	Time	Method
Arterial PO2	Change from baseline (the day before surgery) to postoperative day 1 or 2	Change in arterial PO2
Vital capacity (VC)	Change from baseline (the day before surgery) to postoperative day 1 or 2	Change in VC
Arterial PCO2	Change from baseline (the day before surgery) to postoperative day 1 or 2	Change in arterial PCO2
Forced expiratory volume (FEV1)	Change from baseline (the day before surgery) to postoperative day 1 or 2	Change in FEV1

Trial Locations

Locations (1)

Dept surgery,; 🇸🇪 Umeå, Sweden